BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 563096 · Received January 30, 2005

    Report

    Report Number
    2939301-2004-06384
    Event Type
    Injury
    Date Received
    January 30, 2005
    Date of Event
    December 26, 2004
    Report Date
    December 28, 2004
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MEDICAL AFFAIRS SPOKE TO THE PT'S FAMILIY MEMBER IN 12/2004 AND OBTAINED THE FOLLOWING INFO. THE PT WOKE UP FEELING LETHARGIC, HAD SLURRED SPEECH, AND WAS IN AND OUT CONSCIOUSNESS. FAMILY MEMBER CONTACTED EMERGENCY SERVICES AND TESTED THEIR BLOOD GLUCOSE AND RECEIVED A 277 MG/DL AND GAVE THEM SOME ORANGE JUICE. PARAMEDICS ARRIVED LESS THAN 10 MINUTES AND TOOK THEM TO THE HOSPITAL WERE THEIR BLOOD GLUCOSE WAS 50 MG/DL. PT WAS TREATED WITH GLUCOSE AND KEPT IN THE HOSPITAL OVERNIGHT AND RELEASED THE FOLLOWING MORNING. THE FAMILY MEMBER DID NOT KNOW IF THE SUPPLIES THEIR PT HAD WERE EXPIRED OR THE CONDITION OF THE TEST STRIPS. FAMILY MEMBER DID NOT KNOW HOW LONG THEIR CONTROL SOLUTION HAD BEEN OPENED FOR. FAMILY MEMBER CLAIMS THEIR PT IS ON A SE AMOUNT OF INSULIN AND DOES NOT KNOW MUCH PT TAKES OR HOW MUCH PT TOOK THE NIGHT BEFORE THE INCIDENT. THEIR PHYSICIAN DID NOT CHANGE THEIR DIABETES REGIMEN. FAMILY MEMBER DID NOT HAVE THE DEVICE WITH THEM TO VERIFY THEIR BLOOD GLUCOSE READINGS PRIOR TO THE INCIDENT. BASED ON THE NFO PROVIDED, THIS CASE IS BEING REPORTED AS AN ADVERSE EVENT SINCE THE PT SUFFERED A SERIOUS INJURY; AND THE PHYSICIAN TREATED THE PT FOR THE SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| R